NOVARTIS

Novartis announced updated NATALEE trial results showing Kisqali (ribociclib) reduces distant recurrence by 28.5% in HR+/HER2- early breast cancer patients when combined with endocrine therapy, with consistent DDFS across subgroups. Real-world data highlights high distant recurrence risk despite endocrine therapy, emphasizing the importance of adding CDK4/6 inhibitors like Kisqali for high-risk patients.

Novartis announced positive results from the ASC4FIRST trial showing Scemblix (asciminib) achieved superior major molecular response (MMR) rates at week 96 compared to standard-of-care tyrosine kinase inhibitors (TKIs) in newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia patients. Scemblix demonstrated sustained efficacy, deeper and more durable responses, and favorable safety and tolerability profiles. The drug was recently granted accelerated approval in the US for newly diagnosed and previously treated adult patients with Ph+ CML-CP.

Novartis entered a global license and collaboration agreement with PTC Therapeutics for PTC518, a potential first oral disease-modifying therapy for Huntington's disease. Novartis will pay $1 billion upfront and up to $1.9 billion in milestones, sharing US profits and losses 60/40 with PTC. The deal bolsters Novartis' neuroscience pipeline, focusing on neurodegenerative diseases with high unmet needs.

Despite headwinds, the techbio sector continues to attract significant investment and drive innovation, exemplified by the 2024 launch of Xaira, backed by over $1 billion, aiming to design novel therapeutic proteins using advanced AI. The sector is maturing through strategic consolidation, significant capital deployment, technical diversification, and steady clinical validation, as illustrated by 25 techbio organizations, including notable players like Isomorphic Labs, Generate:Biomedicines, Recursion Pharmaceuticals, and Schrödinger Inc., all leveraging AI for drug discovery. Emerging players such as Archon Biosciences, AION Labs, and Antiverse are also making strides, while established companies like Insilico Medicine and Ginkgo Bioworks continue to expand their platforms and partnerships.

Insomnia market report forecasts growth from 2020 to 2034, driven by increasing prevalence, awareness, and emerging therapies like Seltorexant and TS-142. Challenges include high treatment costs and patient non-compliance, with unmet needs for long-term solutions with minimal side effects.

Adenosine antagonists market growth driven by R&D in neurodegenerative diseases, oncology, and cardiovascular disorders. Innovations in formulation and delivery systems enhance efficacy and safety, increasing adoption. Key companies include Arcus Biosciences, Corvus Pharmaceuticals, Portage Biotech, Palobiofarm, iTeos Therapeutics. Promising drugs like Etrumadenant, Ciforadenant, PORT-6, and Inupadenant are in various clinical trial phases.

Novartis announces positive results for Fabhalta in Phase 3B APPULSE-PNH study, showing improved haemoglobin levels and consistent safety profile. Scemblix also shows superior major molecular response rates in Phase 3 ASC4FIRST study for CML patients.

Iscalimab, a monoclonal antibody targeting an inflammatory pathway in Sjögren’s disease, showed improvements in clinician-reported disease activity and patient-reported dryness and fatigue in a Phase 2b trial, offering hope after prior drug failures.

CD40 targeted therapies in immunotherapy research focus on the CD40 receptor for treating various diseases, with no approvals yet but promising candidates in late-stage clinical development. First approval expected by 2027, with over 20 therapies in trials. Interest in CD40 targeting expands to cancer, infectious diseases, and neurodegenerative diseases. Antibody therapies dominate, with advanced candidates like Sanofi's Frexalimab and Alligator Bioscience's mitazalimab. Proprietary technologies like GenMab's DuoBody platform facilitate development. Major pharmaceutical companies like Amgen, Sanofi, and GenMab are key players, with collaborations advancing research.